I will act as your external prrc according to eu mdr

Germany

I speak English, German

5 orders completed

"I offer professional support in the certification and approval of medical devices within and outside the EU. With extensive experience in MDR certifications, product testing, and the creation of tech...
About this Gig

Are you looking for an external PRRC under Article 15 of the EU MDR (2017/745)? I will evaluate your companys current documentation and compliance structure to determine if I can take over the role of Person Responsible for Regulatory Compliance.


This gig includes:


Review of your current technical documentation (TD), QMS links, PMS/PER setup


Assessment against PRRC requirements (qualifications, responsibilities, MDR readiness)


Written report with identified gaps, risks, and action points


Recommendation whether a PRRC service agreement is possible

Field of law:

Health & medical

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Please note that there is no screening process for this service. We recommend that you message the freelancer and check all necessary details before placing your order. Pro freelancers in this category have gone through a vetting process. You can find more details here.